In the disclosure of the present invention reference is mostly made to the treatment of diabetes by delivery of insulin, however, this is only an exemplary use of the present invention.
For users of medication delivery devices it may be a cumbersome process to keep track of the amount of doses being expelled from the medication delivery device. This process is being further complicated if the time of injection, date of injection etc. are also to be monitored. Addressing this problem a number of solutions have been proposed which would help a user to generate, collect and distribute data indicative of the use of a given medical device.
For example, WO 2007/107564 describes an electronic “add-on” module adapted to be attached to and measure signals generated by a mechanical pen device. The detected signals may be used to detect different events, e.g. different sounds indicating setting a dose respectively ejecting a dose. A memory stores detected doses together with a time stamp, e.g. for several months. The module is provided with wireless means for transmitting detected data to an external unit, e.g. computer or another portable device (e.g. cell phone, PDA) for further processing and visualization. Further external devices for a pen device are shown in U.S. Pat. No. 6,482,185, and WO 03/005891. WO 99/02210 discloses a durable cap for attachment to a mechanical pen device. When the cap is mounted it can be rotated relative to the pen housing and thereby used to set a dose which is then registered in the cap by means of an electronic transducer.
As an alternative to the add-on solution, WO 2006/04552 describes an electronic module adapted to be integrated into a drug delivery device, e.g. a disposable pen device. The module is adapted to record information indicative of a pen dosing parameter, and subsequently transmit data (e.g. time, dose, type of insulin) to an external device for analysis and display. The external device may be in the form of a cap attachable to the pen, the cap providing communication means allowing the cap to transmit data to a further external device, e.g. computer. The cap may be provided with a display showing e.g. time and dose data.
Having regard to the above, it is an object of the present invention to provide devices and methods allowing secure, easy and cost-effective operation of components, devices and systems for the generation, collecting and distribution of data associated with the use of a medical device, especially a drug delivery device.